Home NDC 50844-258-08 Headache Relief
Product NDC 50844-258
Requested package NDC 50844-258-08
11-digit product format 508440258
Labeler code 50844
Product ID 50844-258_9d3ac60b-dab7-4791-a23a-0c9d5f2d030c
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Aspirin, Caffeine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler L.N.K. International, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-07-15
Substance ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength 250; 250; 65 mg/1; mg/1; mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Headache Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 250 mg/1 ASPIRIN 250 mg/1 CAFFEINE 65 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50844-258-08 Headache Relief 24 in 1 BOTTLE TABLET, FILM COATED 24 11 50844-258-08 Headache Relief 1 in 1 CARTON TABLET, FILM COATED 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50844-258 HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20241204_e51fc0d6-9b32-478c-bab7-328013e692b0.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 83 · 1,657 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50844-258-08 50844025808 1 BOTTLE in 1 CARTON (50844-258-08) / 24 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2019-07-15 0000-00-00 No No Current